Cleared Special

K120914 - FLEXITIME FAST & SCAN LIGHT FLOW

K120914 is an FDA 510(k) clearance for FLEXITIME FAST & SCAN LIGHT FLOW, manufactured by Heraeus Kulzer, LLC. The device is a Class 2 Dental device with product code ELW cleared through the Special 510(k) pathway after a 120-day FDA review.

K120914 · Heraeus Kulzer, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
120d
Days
Class 2
Risk

K120914 is an FDA 510(k) clearance for the FLEXITIME FAST & SCAN LIGHT FLOW. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on July 25, 2012 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120914

510(k) Number K120914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2012
Decision Date July 25, 2012
Days to Decision 120 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 128d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 364
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K120914.
FLASH AR PENTA / FLASH AR PENTA QUICK
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K113574 · Heraeus Kulzer, LLC · Jul 2012
TEMPSPAN CLEAR MATRIX
K120013 · Pentron Clinical · May 2012
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012